Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Lurbinectedin
Eligibility
Inclusion Criteria:
1. Signed informed consent
2. ≥ 18 years of age
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate organ and bone marrow function
5. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
6. Have advanced (metastatic/unresectable) cancers in one of the following:
1. Histologically or cytologically confirmed urothelial cancer
2. Histologically or cytologically confirmed poorly differentiated neuroendocrine
carcinoma
3. Histologically or cytologically confirmed homologous recombination
deficient-positive malignancies agnostic, which may include endometrial, biliary
tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or
esophageal solid tumors with preidentified germline and/or somatic pathogenic
mutation
7. Adequate contraceptive precautions
Exclusion Criteria:
1. Known symptomatic central nervous system (CNS) metastasis requiring steroids
2. History of prior malignancy within 2 years of enrollment
3. Clinically significant cardiovascular disease
4. Active infection requiring systemic therapy
5. Significant non-neoplastic liver disease
6. Prior treatment with trabectedin or lurbinectedin
7. Treatment with an investigational agent within 4 weeks of enrollment
8. Received live vaccine with 4 weeks of first dose
9. Prior allogeneic bone marrow or solid organ transplant
10. Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
11. Positive human immunodeficiency virus (HIV) infection at screening
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paige Nicole Baker
650-736-3687
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.